Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Randomised controlled trial of early introduction of allergenic foods to induce tolerance in infants

Acronym

EAT (Enquiring About Tolerance)

Study hypothesis

1. The early introduction of allergenic foods (from three months of age) will induce regulatory mechanisms that result in a reduced level of food allergy by three years of age. The effect on food sensitisation at three years of age will be determined. 2. The early introduction (from three months of age) of allergenic foods into the infant's diet may lead to a reduction in the prevalence of other allergic conditions by three years of age: specifically asthma (including atopic wheeze), eczema, allergic rhinitis (including aero-allergen sensitisation) combined food allergy prevalence (including food sensitization) and the prevalence of combined allergic disease. 3. The early introduction of allergenic foods does not have any deleterious effects

Patient information sheet

Condition

Intervention

The intervention arm consists of the dietetic controlled introduction of allergenic foods from three months of age. Baby rice mixed with breast milk or water will be commenced first, followed by cow's milk based yoghurt. Subsequently egg, wheat, sesame, fish and peanut will be sequentially introduced into the diet in high doses with each food being ingested 2 times a week achieving a total ingestion of 4 g or more per week of each food protein by five months of age.

Mothers will not introduce wheat before 4 months of age. Infants in the intervention arm will be required to consume the allergenic foods until the one-year assessment at which point ongoing consumption of all six allergenic foods will be encouraged until the end of the study when subsequent consumption will be a matter of parental choice.

The control arm will follow standard UK Government weaning advice (exclusive breast feeding until around 6 months of age) and no early introduction of allergenic foods (egg, wheat, peanuts, tree nuts, seeds, fish and shell fish) before six months of age.

Total duration of follow-up: Infant: from 3 months to 3 years of age

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The period prevalence of IgE mediated food allergy to the six intervention foods between one and three years of age in both arms

Secondary outcome measures

1. Period (one to three years of age) prevalence food outcomes: 1.1. The period prevalence of all IgE mediated food allergy between one and three years of age in both arms1.2. The period prevalence of all food allergy (IgE and non-IgE mediated) between one and three years of age in both arms1.3. The period prevalence of sensitisation to food between one and three years of age in both arms

2. Cumulative (by three years of age) prevalence food outcomes: 2.1. The cumulative prevalence of IgE mediated food allergy to the six intervention foods by three years of age. 2.2. The cumulative prevalence of all IgE mediated food allergy by three years of age2.3. The cumulative prevalence of all food allergy (IgE and non-IgE mediated) by three years of age2.4. The cumulative prevalence of non-IgE mediated food allergy by three years of age2.5. The cumulative prevalence of sensitization to the six foods by three years of age

3. Other allergic disease outcomes: 3.1. The point prevalence of eczema at one year and three years of age and cumulative prevalence of eczema by three years of age3.2. The severity of eczema at one year and three years of age by Severity Scoring of Atopic Dermatitis index (SCORAD) and Nottingham Eczema Severity Score (NESS)3.3. The prevalence of allergic rhinitis at three years of age3.4. The prevalence of inhalant allergen sensitisation at one year and at three years of age by skin prick test 3.5. The prevalence of inhalant allergen sensitisation at one year and at three years of age by specific IgE measurement 3.6. The prevalence of the atopic wheeze phenotype at three years of age

4. Composite allergy outcome: 4.1. The prevalence of combined allergic disease (a composite of cumulative IgE mediated food allergy to all foods, atopic wheeze phenotype, eczema and allergic rhinitis) at three years of age 4.2. The prevalence of combined allergic disease (a composite of cumulative IgE and non-IgE mediated food allergy to all foods, atopic wheeze phenotype, eczema and allergic rhinitis) at three years of age

Participant inclusion criteria

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

3,000 pregnant women (2,500 infants)

Participant exclusion criteria

1. Significant antenatal anomaly at 20 week ultrasound scan2. Multiple pregnancy3. Significant congenital disease (enteropathy, congenital heart disease, renal disease)4. Premature delivery (less than 37 completed weeks gestation)5. Parents not planning on breast feeding exclusively for at least the first 3 months6. Parents planning on moving away from London before their child is three years of age7. Parents unable to speak and read English8. Unwillingness or inability to comply with study requirements and procedures9. Family intend infant to be on a restricted diet (any of the six intervention foods)